A Comparison of User-adjusted and Audiologist-adjusted Hearing Amplification
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Real-ear aided output
研究概览
简要总结
Fifty adults with mild to moderately severe sensorineural hearing loss will be fit with hearing amplification using two adjustment techniques. For the "audiologist fitting" technique, a licensed audiologist will adjust the hearing device using the standard of care procedures which include adjustment and verification of output to match prescribed targets (NAL-NL2) and subsequent fine tuning to optimize adjustments based on participant feedback. The second technique is "user-adjustment" of the device consisting of adjustment to overall level, high-frequency boost, and low-frequency cut by the participant while listening to speech. A cross-over design will be used in which half the participants are initially fit using the audiologist technique and the other half are initially fit using the user self-adjustment technique. Following a seven-day field trial, participants will return to the lab and the aids will be reset use the other technique. Participants will be blinded to the condition. During each seven-day field trial, users will have access to a volume control, Following the end of the two trials, participants will return to the lab for outcome assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Outcomes assessors and participants will not be aware of which hearing setting (audiologist adjusted vs. self-adjusted) they are wearing
入排标准
- 年龄范围
- 50 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •bilateral hearing loss with a minimum of 40 dB HL thresholds at 2000 Hz
- •English speaking
排除标准
- •Score less than 21 on the MoCa (Montreal Cognitive Assessment)
- •Evidence of conductive or retrocochlear pathology
结局指标
主要结局
Real-ear aided output
时间窗: two weeks
aided output (in dB SPL) measured across frequencies in the ears of the participants
次要结局
- Computerized Assisted Speech Perception Assessment (CASPA)(two weeks)
- Device Oriented Scale of Improvement (DOSO)(two weeks)
研究者
Carol L Mackersie
Professor
San Diego State University
